FDA Approvals, News & Updates
Nucala (Mepolizumab): First IL-5 Antagonist Monoclonal Antibody FDA Approved for Maintenance Treatment of Patients with Severe Asthma
Asthma, a condition characterized by the narrowing and inflammation of airways and excess mucus, affects 1 in 12 individuals in the United States—approximately 25 million people, or 8% of the US population.
Pomalyst (Pomalidomide) Received a New Indication for Patients with Relapsed and/or Refractory Multiple Myeloma
Multiple myeloma is a cancer of plasma cells in the bone marrow that often leads to bone destruction and bone marrow failure. According to the American Cancer Society, more than 26,800 new cases of multiple myeloma were diagnosed in 2015, and 11,240 deaths were attributed to the disease.
Portrazza (Necitumumab), an IgG1 Monoclonal Antibody, FDA Approved for Advanced Squamous Non–Small-Cell Lung Cancer
Coronary heart disease, more often referred to as cardiovascular disease (CVD) today, is a leading cause of illness and death in the United States. Many risk factors contribute to CVD, including age, family history, obesity, lack of physical activity, diet, smoking, high blood pressure, and high blood cholesterol (hypercholesterolemia).
Repatha (Evolocumab): Second PCSK9 Inhibitor Approved by the FDA for Patients with Familial Hypercholesterolemia
Hypercholesterolemia, a condition characterized by high levels of cholesterol in the blood, is a major controllable risk factor for coronary heart disease, myocardial infarction, and stroke. The risk for cardiovascular disease (CVD) in individuals with high cholesterol is approximately twice that for people with lower cholesterol.
Multiple myeloma is a cancer of plasma cells in the bone marrow that often leads to bone destruction and bone marrow failure. According to the American Cancer Society, more than 26,800 new cases of multiple myeloma were diagnosed in 2015, and 11,240 deaths were attributed to multiple myeloma in the same year.
Tresiba (Insulin Degludec Injection) and Ryzodeg 70/30 (Insulin Degludec and Insulin Aspart Injection): Two New Insulin Analogs for Glycemic Control in Diabetes Mellitus
More than 29 million people in the United States have diabetes, the seventh leading cause of mortality and a major cause of stroke, heart disease, kidney failure, blindness, and other serious conditions. As the US population ages and the number of higher-risk minority groups grows, the incidence of diabetes is projected to nearly double from approximately 8 cases per 1000 individuals in 2008 to approximately 15 cases per 1000 in 2050.
Colony-stimulating factors (CSFs) are endogenous glycoproteins that regulate the production and the functioning of infection-protective granulocytes and macrophages. Overall, 2 types of recombinant CSF drugs—granulocyte CSF (filgrastim, pegfilgrastim) and granulocyte-macrophage CSF (sargramostim)—have been prescribed for more than 20 years to stimulate neutrophils and macrophages, primarily in patients with cancer who are undergoing treatment with cytotoxic chemotherapy.
Rheumatoid arthritis (RA) is a systemic, inflammatory form of arthritis that results in joint inflammation, pain, swelling, and stiffness. Although new treatment strategies that focus on early diagnosis, aggressive treatment, and consistent monitoring have helped many patients achieve their goals, RA continues to present clinical and economic challenges to patients, physicians, and payers.
Omnigraft (Integra Omnigraft Dermal Regeneration Matrix) has been approved by the FDA to treat patients with diabetes who have certain foot ulcers. The device, which is made of silicone, cow collagen, and shark cartilage, provides an environment for new skin and tissue to regenerate and heal the wound when placed over an ulcer.
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Results 91 - 100 of 148
Results 91 - 100 of 148